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Three classess of tests are now recommended in the latest consolidated guideles on tests for tuberculosis infection. It includes for the first-time a new class of Mycobacterium tuberculosis antigen-
...
based skin tests (TBSTs), and the two existing classes of tests: the tuberculin skin test (TST) and the interferon-gamma release assays (IGRAs).
IGRAs and TBSTs use Mycobacterium tuberculosis complex specific antigens and represent a significant advancement to TST which has been used for over half a century.
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Technical specifications series for submission to WHO prequalification: diagnostic assessment;TSS-3
This document provides technical guidance for manufacturers seeking World Health Organization (WHO) prequalification of in vitro diagnostic devices (IVDs) for malaria, with a focus on rapid diagnostic tests (RDTs) for symptomatic patients. It summar
...
ises the minimum performance requirements, including analytical and clinical performance standards, and emphasises considerations relating to diverse specimen types, testing environments and user populations in low- and middle-income countries. The guidance is aligned with the criteria and prequalification processes of the WHO Global Malaria Programme, while clarifying that demonstration of clinical utility is outside the scope of prequalification.
more
This document provides technical guidance for manufacturers seeking World Health Organization (WHO) prequalification of in vitro diagnostic devices (IVDs) for malaria, with a focus on rapid diagnostic tests (RDTs) for symptomatic patients. It summar
...
ises the minimum performance requirements, including analytical and clinical performance standards, and emphasises considerations relating to diverse specimen types, testing environments and user populations in low- and middle-income countries. The guidance is aligned with the criteria and prequalification processes of the WHO Global Malaria Programme, while clarifying that demonstration of clinical utility is outside the scope of prequalification.
more
Accessed Febr. 6, 2020
This guide provides an overview of the major elements that must be considered before, during and after the implementation of antigen-detecting rapid diagnostic tests (Ag-RDTs) for SARS-CoV-2. This guide is complementary to policy guidance issued by
...
the World Health Organization (WHO). The guide may appeal to a range of audiences including Ministries of Health, donors, public and private organizations/agencies acting as implementing partners and community based and civil society organizations with experience working on health, especially organizations familiar with similar testing campaigns for other disease programmes like HIV and malaria
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Guidelines on lenacapavir for HIV prevention and testing strategies for long-acting injectable pre-exposure prophylaxis. Web Annex D
This algorithm is addressed to laboratories
with established capacity(molecular, antigenic and/orserological) to detect dengue (DENV), Zika (ZIKV), and chikungunya(CHIKV) as part of the differential diagnosis for arborviruses. A BSL2 containment level is required to handle suspected samples.
Copenhagen, Denmark, 24–25 August 2017
Polymerase Chain Reaction (PCR) has significantly helped in early diagnosis and commencement of specific interventions for diseases control. It also plays a critical role in understanding the disease epidemiology and unraveling the transmission dynamics of the disease. This manual intends to p
...
rovide primary guidelines to assist health lab personnel in developing countries to establish a PCR diagnostic facility for efficient support to patient care as well as public health actions.
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The National Guidelines for HIV-1 Viral Load Laboratory Testing support plans to scale up viral load (VL) testing to reach the 90-90-90 targets in India. This phased scale-up includes the setup of 70 additional VL testing laboratories nationally. Th
...
ese guidelines include laboratory design considerations, a summary of VL technologies, and specimen collection and handling as well as transportation and storage guidance. Quality control and quality assurance requirements are described as well as laboratory safety issues. The guidelines also describe the VL laboratory network to be developed with supply chain management issues and commodities described. Annexes include laboratory registers and reporting forms.
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This document provides brief information answering common questions regarding COVID-19 diagnostic tests and how to prioritize them to the patients most in need.
In 2019, an estimated 10 million individuals fell ill with tuberculosis (TB) and 3 million of them were not reported to have beendiagnosed and notified. The gap is proportionately even wider for drug-resistant TB. Of the estimated 465 000 patients with rifampicin-resistant and multi-drug resistant T
...
B (RR/MDR-TB), only 206 030 (44%) were diagnosed and notified.For the first time, the World Health Organization (WHO) has provided global estimates of the incidence of isoniazid resistance: in 2019, there were 1.4 million incident cases of isoniazid-resistant TB, of which 1.1 million were susceptible to rifampicin. Most of these people were not diagnosed with drug-resistant TB and did not receive appropriate treatment.
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Au total, 18 laboratoires de 13 pays ont participé aux quatre cycles d'AQE : 10 laboratoires de huit pays africains endémiques, dont quatre ont participé aux quatre cycles et trois à trois cycles. Les résultats globaux ont montré que la performance médiane de ces laboratoires s'est amélioré
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e au cours des quatre cycles. Cependant, la proportion de laboratoires rapportant des cas faussement positifs reste élevée et indique un problème de spécificité probablement dû à une contamination. La proportion de laboratoires rapportant à la fois des résultats faussement positifs et faussement négatifs soulève la question de la qualité des données rapportées par l'OMS en Afrique ainsi que des résultats des études menées dans ces différents laboratoires dans divers pays.
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Despite being a preventable and curable infectious disease, tuberculosis (TB) has continued to elude global controll efforts. In 2023, 8.2 milion people with TB were diagnosed and notified to the WHO, the hightest number ever reported since WHO began tracking.
Epidemic Preparedness and Response in Africa | Guidelines for the Decentralization of Laboratory Capacity
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The decentralization of laboratory capacities is a critical strategy for improving epidemic preparedness and response in Africa. Centralized systems often delay case confirmation, hinder timely interventions, and exacerbate the impact of outbreaks,
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especially in rural and hard-to-reach areas.
This Guidelines outlines a structured approach to decentralization, focusing on:
Strategic Goals: Strengthening laboratory capacity at subnational levels to ensure timely detection and control of epidemic-prone diseases.
Guiding Principles: Equity, country ownership, multisectoral collaboration and evidence-based decision-making.
Implementation Framework: Practical steps for planning, executing, and sustaining decentralized diagnostic networks, with intra- and post-implementation reviews for continuous improvement.
Integration: Alignment with existing surveillance, case management and infection prevention and control (IPC) systems, with a focus on the One Health approach.
While the Guidelines is informed by the Mpox outbreak response, it is adaptable to other priority diseases and aligned with the International Health Regulations (IHR 2005), the Africa CDC Strategic Plan (2022-2027), and the WHO Health Security Framework.
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Tuberculosis. Practical guide for clinicians, nurses, laboratory technicians and medical auxiliaries
This Tuberculosis guide has been developed jointly by Médecins Sans Frontières and Partners In Health. It aims at providing useful information to the clinicians and health staff for the comprehensive management of tuberculosis. Forms of susceptible and resistant tuberculosis, tuberculosis in child
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ren, and HIV co-infection are all fully addressed.
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